KALAZAR DETECT— 510(k) K023483

Substantially Equivalent

Inbios Intl., Inc.

FDA 510(k) clearance K023483 for KALAZAR DETECT, Substantially Equivalent on 2003-05-06. Applicant: Inbios Intl., Inc.. Device class: 1.

Clearance details

Applicant: Inbios Intl., Inc.
Product code: Code LOO
Device class: Class 1
Regulation: 21 CFR 866.3870
Advisory panel: Microbiology
Date received: 2002-10-17
Decision date: 2003-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.